f Post-Approval Studies (PAS) Database
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
  • Print
  • Share
  • E-mail
-

The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

Learn more...


           
   
  Active Orders
Suggest Enhancement / Report Issue | export reports to excelExport to Excel
Sort By Application Number Application
Number		 Sort By Application Number -- Descending
Sort By Manufacturer Applicant Sort By Manufacturer -- Descending
   Sort By Device Name Device
Name		 Sort By Device Name -- Descending
Sort By Medical Specialty Medical
Specialty		 Sort By Medical Specialty -- Descending
Sort By Date Order Date PMA
Approved		 Sort By Date Order -- Descending
Study
Name
Study Status
P070004 SIENTRA, INC SIENTRA SILICONE GEL BREAST IMPLANTS General &
Plastic Surgery		 03/09/2012 Post-Approval PMA Cohorts Study (PACS) Completed
Post-Approval Cont Access Study (PACAS) Completed
Focus Group Study Completed
US Post-Approval Study (US-PAS) Delayed
Post-Approval Case-Control Studies(PACCS) Terminated


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

-
-